The technology institute for the Brazilian state of Paraná, which has signed an agreement to produce Russia’s Sputnik V coronavirus vaccine, said on Friday it plans to conduct phase III trials on 10,000 volunteers in Brazil at the start of next year.
Jorge Callado, head of Paraná’s Technology Institute, known as Tecpar, said approval for the trial will be requested of Brazil’s health regulator ANVISA by the end of this month. Doses will be imported for the tests and Tecpar plans to produce the vaccine for Brazil’s market in the second half of 2021, he said.
Doses will be imported for the tests and Tecpar plans to start producing the vaccine for Brazil’s market in the second half of 2021. Tecpar could eventually look to export to Latin American neighbors.
Callado said R$ 200 million reais ($38 million) have been earmarked to purchase the vaccines, used firstly to inoculate the state’s population
The Sputnik V vaccine produced an antibody response in all participants in early-stage trials, according to results published on Friday by The Lancet medical journal that were hailed by Moscow as an answer to its critics.
The results of the two trials, conducted in June-July this year and involving 76 participants, showed 100% of participants developing antibodies to the new coronavirus and no serious side effects.
Russia licensed the two-shot jab for domestic use in August, the first country to do so and before any data had been published or a large-scale trial begun.
Russia has said it expects to produce between 1.5 million and 2 million doses per month of its potential vaccine by the end of the year, gradually increasing production to 6 million doses a month.